A Study Evaluating an Implantable Cardiac Microcurrent Device in Patients With Chronic Heart Failure

NCT07795359 | Not Yet Recruiting

• 1 other identifier: C-MIC-IV
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the safety and performance/effectiveness of the C-MIC System, an active implantable medical device designed to treat patients with heart failure with reduced ejection fraction (HFrEF). The system delivers a non-excitatory, constant direct electrical microcurrent (DC) to the heart with the aim of improving cardiac function. The C-MIC System is intended for use in patients with ischemic or non-ischemic dilated cardiomyopathy who have symptomatic, ambulatory heart failure despite receiving guideline-directed medical therapy. Eligible patients must have a left ventricular ejection fraction (LVEF) between ≥20% and ≤40%. The device is implanted in the catheterization laboratory using a minimally invasive procedure that does not require open-heart surgery. Following implantation, patients receive C-MIC Therapy for a duration of six months. The therapy is designed to improve left ventricular performance, as well as functional capacity and patient well-being, including 6-minute walk distance, quality of life, and New York Heart Association (NYHA) functional class.

Conditions

Chronic Heart Failure; Left Ventricular (LV) Systolic Dysfunction; Ischemic and Non-ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (6)

• Change From Baseline in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score at Month 6

  The Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) assesses heart failure symptoms and physical limitations. Scores range from 0 to 100, with higher scores indicating better health status. Change from baseline is calculated as the Month 6 score minus the baseline score; a positive change indicates improvement.

  From baseline to 6 months

• Change From Baseline in 6-Minute Walk Distance at Month 6

  The 6-Minute Walk Test measures functional exercise capacity as the distance, in meters, that a participant can walk in 6 minutes. Change from baseline is calculated as the Month 6 distance minus the baseline distance; a positive change indicates improvement.

  From baseline to 6 months

• Ordinal Shift From Baseline in New York Heart Association Functional Class at Month 6

  New York Heart Association (NYHA) Functional Class is a clinician-assessed, 4-category ordinal classification of heart failure severity: Class I indicates no limitation of physical activity, Class II indicates slight limitation, Class III indicates marked limitation, and Class IV indicates symptoms at rest. A shift to a lower class indicates improvement, and a shift to a higher class indicates worsening.

  From baseline to 6 months

• Patient Global Assessment of Change Score at Month 6

  The Patient Global Assessment of Change is a participant-reported assessment of overall change in health status relative to baseline. It is measured on a 7-point ordinal scale ranging from 1 ("markedly worse") to 7 ("markedly improved"), with 4 indicating "no change." Higher scores indicate a more favorable assessment.

  6 months

• Percentage of Participants Who Are Echocardiographic Responders at Month 6

  An echocardiographic responder is a participant who meets at least 1 of the following criteria at Month 6 compared with baseline: * Increase in left ventricular ejection fraction (LVEF) of at least 5 percentage points * Improvement in global longitudinal strain (GLS) of at least 2 percentage points, defined as an increase in the absolute magnitude of GLS * Relative reduction in left ventricular end-diastolic volume index (LVEDVi) of at least 10% * Relative reduction in left ventricular end-systolic volume index (LVESVi) of at least 10% Each participant will be counted once as a responder if at least 1 criterion is met. The outcome will be reported as the percentage of participants classified as echocardiographic responders.

  From baseline to 6 months

• Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide Concentration at Month 6

  N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a blood biomarker of heart failure severity and is measured in picograms per milliliter (pg/mL). Change from baseline is calculated as the Month 6 concentration minus the baseline concentration; a negative change indicates a reduction in NT-proBNP.

  From baseline to 6 months

Secondary Outcomes (1)

• Change in Left Ventricular Ejection Fraction From Month 6 to Month 12

  From 6 monts to 12 months

Study Arms (2)

Stratum 1: Ischemic Etiology

OTHER

Stratum 1a: Active → Inactive Stratum 1b: Inactive → Active

Device: Subcutaneous cardiac microcurrent treatment

Stratum 2: Non-Ischemic Etiology

OTHER

Stratum 2a: Active → Inactive Stratum 2b: Inactive → Active

Device: Subcutaneous cardiac microcurrent treatment

Interventions

Subcutaneous cardiac microcurrent treatment DEVICE

The C-MIC System is implanted subcutaneously using a minimally invasive, non-open-heart procedure performed in a catheterization laboratory. Following randomization, C-MIC Therapy is either inactive or active from Day 1 through Day 180 and active or inactive, respectively, from Day 180 through Day 360.

Stratum 1: Ischemic Etiology; Stratum 2: Non-Ischemic Etiology

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only for Stratum 1: Patients with HFrEF with non-ischemic disease etiology1
• Only for Stratum 2: Patients with HFrEF with ischemic disease etiology. All Participants
• Informed consent in writing obtained from patient.
• Ambulatory patients with symptomatic chronic heart failure in NYHA functional class II-IV at the time of screening lasting for more than 1 year based on the date of diagnosis. Participants in NYHA II at screening must have one documented episode of NYHA III during the prior 6 months with either hospitalization or increase of heart failure medication dosage.
• Documented worsening heart failure episode within 12 months prior to screening, defined as HF hospitalization, requirement for intravenous diuretic therapy, or escalation of oral diuretic therapy due to clinically significant worsening HF symptoms requiring medical intervention, as evidenced by source documentation.
• Patients who have a baseline LVEF of ≥ 20 % and ≤ 40 % in echocardiography as assessed by the core-lab within 30 days prior to device implantation.
• Female and male patients aged 18 years to ≤ 80 years.
• Patients receiving appropriate, stable guideline-directed medical therapy for heart failure for at least 90 days prior to screening. \[Note: Stable therapy is defined as no more than a 50 % increase or 50 % decrease in dose. If a patient is unable to take guideline recommended doses of heart failure medication, documented evidence must be available.\]
• Patients who are able to perform a 6-minute walk test. At screening, the 6-minute walk test distance is between 100 and 450 m.
• Body habitus that, in the opinion of the Investigator, permits safe and feasible implantation of the C-MIC System, including adequate anatomical access and visualization required for the procedure

You may not qualify if:

• Patients who are not likely to experience improvement of their chronic heart failure by the microcurrent therapy, because the causes of the disease cannot be influenced even if the patients fulfill the indication for use of the device or if the therapy with the C MIC System is not possible or might be associated with unknown risks:
• Patients who have a potentially correctible cause of heart failure, such as severe valvular heart disease or congenital heart disease.
• Patients with an indication for a CRT system according to current guidelines.
• Patients who have been hospitalized for heart failure which required the use of inotropic support within 90 days before screening.
• Patients with systolic blood pressure (SBP) above 150 mmHg and diastolic blood pressure (DBP) above 90 mmHg despite optimal antihypertensive medical treatment.
• Patients with SBP \< 90 mmHg at screening while not receiving vasopressor therapy, as assessed by the Investigator.
• Patients with hemoglobin blood level \< 11 g/dL.
• Patients with primary severe pulmonary hypertension defined as estimated systolic pulmonary artery pressure (SPAP) \> 80 mmHg on screening echocardiography.
• Patients who have genetic connective tissue disease (for example Marfan syndrome).
• Patients with a prosthetic tricuspid valve.
• Patients in whom access for implantation of the leads cannot be obtained (i.e. known venous occlusion, post radiation therapy).
• Patients with other anatomical features (e.g., thoracic deformities) that, in the investigator's judgment, would make straightforward device placement unlikely.
• Patients with a pacemaker, an ICD system, a CRT system or with a CCM system\* \[\* In case the patient requires a pacemaker or has a CCM device, the impulses given from the device could change the C-MIC System setting into a safe state and stop the microcurrent.\]
• Current pregnancy or Breast feeding/lactating women
• Women of childbearing potential (WOCBP), defined as all women who are physiologically capable of becoming pregnant, unless they are using a highly effective methods of contraception (failure rate \< 1 % per year), as determined by the investigator, for at least 2 months prior to C-MIC therapy and continuing until 1 month after completion of therapy

Sponsors & Collaborators

• Berlin Heals GmbH: lead

Related Links

• Related Info

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Faouzi Kallel

CONTACT

+1 5106733971; kallel@berlinheals.de

John Brumfield

CONTACT

+49 1512 6220275; brumfield@berlinheals.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share